LOSARTAN/HYDROCHLOROTHIAZIDE ALMUS 50 mg/12.5 mg FILM-COATED TABLETS

2. What you need to know before taking Losartan/Hydrochlorothiazide Almus

Do not takeLosartan/Hydrochlorothiazide Almus

• if you are allergic to losartan, hydrochlorothiazide, or any of the other components of this medication (listed in section 6).
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g., other thiazides, some antibacterials such as cotrimoxazole; ask your doctor if you are unsure).
• If you are pregnant for more than 3 months. It is also best to avoid Losartan/Hydrochlorothiazide Almus during the first months of pregnancy (see pregnancy section).
• if you have severe liver failure.
• if you have severe kidney failure or your kidneys do not produce urine.
• if you have low potassium or sodium levels, high calcium levels that cannot be corrected with treatment.
• if you have gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

Inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will generally recommend that you stop taking Losartan/Hydrochlorothiazide Almus before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan/Hydrochlorothiazide Almus. Losartan/Hydrochlorothiazide Almus is not recommended for use at the start of pregnancy, and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from this time.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartan/Hydrochlorothiazide Almus. Your doctor will decide whether to continue treatment. Do not stop taking Losartan/Hydrochlorothiazide Almus on your own.

It is essential that you inform your doctor before taking Losartan/Hydrochlorothiazide Almus:

• if you have previously suffered from swelling of the face, lips, tongue, or throat
• if you are taking diuretics (medications to urinate)
• if you are on a low-salt diet
• if you have had excessive vomiting and/or diarrhea
• if you have heart failure
• if you have narrow arteries that supply the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant
• if you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have narrowing of the aortic or mitral valve (heart valve narrowing) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)
• if you are diabetic
• if you have had gout
• if you have had an allergic disorder, asthma, or a condition that causes joint pain, skin rashes, and fever (systemic lupus erythematosus)
• if you have high calcium levels or low potassium levels or if you are on a low-potassium diet
• if you need to undergo anesthesia (even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you should inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland).
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems.
• aliskiren

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Losartan/Hydrochlorothiazide Almus.
• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within a few hours to a week after taking losartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing this.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Losartan/Hydrochlorothiazide Almus, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Losartan/Hydrochlorothiazide Almus".

Taking Losartan/Hydrochlorothiazide Almus with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Almus may interact with other medications. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Almus without your doctor's careful monitoring. Special precautions (e.g., blood tests) may be necessary if you take potassium supplements, potassium-containing salt substitutes, or potassium-sparing medications, diuretics (water pills), certain laxatives, medications for gout, medications to control heart rhythm or diabetes (oral medications or insulins). It is also important that your doctor knows if you are taking other medications to lower your blood pressure, steroids, cancer medications, pain medications, antifungal medications, or arthritis medications, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills; opioid medications like morphine, "pressor amines" like adrenaline or other medications in the same group; (oral diabetes medications or insulins).

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Losartan/Hydrochlorothiazide Almus" and "Warnings and precautions").

Please, when taking Losartan/Hydrochlorothiazide Almus, inform your doctor when you plan to undergo a contrast medium with iodine.

Taking Losartan/Hydrochlorothiazide Almus with food, drinks, and alcohol

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide Almus tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of Losartan/Hydrochlorothiazide Almus tablets.

Losartan/Hydrochlorothiazide Almus can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will generally recommend that you stop taking Losartan/Hydrochlorothiazide Almus before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan/Hydrochlorothiazide Almus. Losartan/Hydrochlorothiazide Almus is not recommended for use at the start of pregnancy, and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from this time.

Breastfeeding:

Inform your doctor if you are breastfeeding or plan to start breastfeeding. The use of Losartan/Hydrochlorothiazide Almus is not recommended during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Consult your doctor or pharmacist before using any medication.

Use in children and adolescents

There is no experience with the use of Losartan/Hydrochlorothiazide in children. Therefore, Losartan/Hydrochlorothiazide Almus should not be administered to children.

Use in elderly patients

Losartan/Hydrochlorothiazide Almus works with equal efficacy and is equally well tolerated by most elderly patients and young patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When starting treatment with this medication, you should not perform tasks that require special attention (e.g., driving a car or using hazardous machinery) until you know how your medication is tolerated.

Losartan/Hydrochlorothiazide Almuscontains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Use in athletes:

This medication contains hydrochlorothiazide, which may produce a positive result in doping tests.

3. How to take Losartan/Hydrochlorothiazide Almus

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide Almus, depending on your condition and whether you are taking other medications. It is essential to continue taking Losartan/Hydrochlorothiazide Almus as prescribed by your doctor to maintain constant blood pressure control.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 losartan/hydrochlorothiazide 50 mg/12.5 mg tablet per day to control blood pressure for 24 hours. It can be increased to 2 film-coated losartan/hydrochlorothiazide 50 mg/12.5 mg tablets per day or changed to 1 film-coated losartan/hydrochlorothiazide 100 mg/25 mg tablet (a stronger dose) per day. The maximum daily dose is 2 losartan 50 mg/hydrochlorothiazide 12.5 mg tablets per day or 1 losartan 100 mg/hydrochlorothiazide 25 mg tablet per day.

If you take moreLosartan/Hydrochlorothiazide Almusthan you should

In case of an overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to takeLosartan/Hydrochlorothiazide Almus

Try to take Losartan/Hydrochlorothiazide Almus as prescribed by your doctor. However, if you forget a dose, do not take an extra dose. Simply return to your regular schedule.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide Almus tablets and inform your doctor immediately or go to the emergency department of your nearest hospital:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that can cause difficulty swallowing or breathing).

This is a serious but rare adverse effect, which affects more than 1 patient in 10,000 but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

The following adverse effects have been reported:

Frequent (may affect up to 1 in 10 people):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorder,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• High potassium levels (which can cause an abnormal heart rhythm), decreased hemoglobin levels.
• Changes in kidney function, including kidney failure
• Low blood sugar (hypoglycemia)

Uncommon (may affect up to 1 in 100 people):

• Anemia, red or brown spots on the skin, (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), hematoma, reduced white blood cell count, coagulation problems, decreased platelet count
• Loss of appetite, high uric acid levels or gout, high blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment,
• Numbness or similar sensations, pain in the limbs, tremors, migraine, fainting,
• Blurred vision, eye irritation or itching, conjunctivitis, worsening vision, seeing things in yellow,
• Ringing, buzzing, noises, or clicking in the ears, vertigo
• Low blood pressure that may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient stroke, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels that is often associated with a skin rash or hematoma,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion,
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), pancreatitis,
• Hives, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss,
• Pain in the arms, shoulders, hips, knees, or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination even at night, abnormal kidney function, including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual desire, impotence,
• Swelling of the face, localized swelling (edema), fever.

Rare (may affect up to 1 in 1,000 people):

• Hepatitis (liver inflammation), abnormal liver function tests.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare (may affect less than 1 in 10,000 people):

• Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

Unknown (frequency cannot be estimated from available data):

• Flu-like symptoms
• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis)
• Low sodium levels in the blood (hyponatremia)
• Generally feeling unwell (malaise)
• Taste disturbance (dysgeusia)
• Skin and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Reporting adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Losartan/Hydrochlorothiazide Almus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

Store Losartan/Hydrochlorothiazide Almus in the original package. Do not store above 30°C. Keep the blister in the outer packaging. Do not open the blister until you are ready to take the tablet.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan/Hydrochlorothiazide Almus

The active substances are losartan potassium and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide Almus 50 mg/12.5 mg film-coated tablet contains, as active substances, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

Losartan/Hydrochlorothiazide Almus 50 mg/12.5 mg film-coated tablets contain the following inactive ingredients: Lactose monohydrate, Microcrystalline cellulose, Hydroxypropyl cellulose, Pregelatinized corn starch, Magnesium stearate.

Losartan/Hydrochlorothiazide Almus 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

Losartan/Hydrochlorothiazide Almus 50 mg/12.5 mg film-coated tablets also contain: Opadry Y-1-7000 White:Hypromellose, Titanium dioxide (E-171), Polyethylene glycol 400.

Appearance and Package Contents of the Product

Losartan/Hydrochlorothiazide Almus 50 mg/12.5 mg tablets are supplied as white, oblong, and scored film-coated tablets.

Losartan/Hydrochlorothiazide Almus 50 mg/12.5 mg film-coated tablets are supplied in packages of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

Date of the Last Revision of this Leaflet: February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/